GENCARE DAYTIME COLD AND FLU SOFTGEL- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Gencare DayTime Cold and Flu Softgel by

Drug Labeling and Warnings

Gencare DayTime Cold and Flu Softgel by is a Otc medication manufactured, distributed, or labeled by Pioneer Life Sciences, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

Acetaminophen 325mg.....................Pain reliever/fever reducer
Dextromethorphan HBr 10mg..................... Cough suppressant
Phenylephrine HCl 5mg ............................. Nasal decongestant

Uses:

temporarily relieves common cold/flu symptoms:
■ nasal congestion

■ cough due to minor throat & bronchial irritation

■ sore throat

■ headache

■ minor aches & pains

■ fever

Warning

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 4 doses in 24 hrs, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product.

Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting,consult a doctor promptly.

Do not use:

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist 
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or
  Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

ASK DOCTOR

Ask a doctor before use if you have

■ liver disease

■ heart disease

■ thyroid disease

■ diabetes

■ high blood pressure

■ trouble urinating due to enlarged prostate gland

■ cough that occurs with too much phlegm (mucus)

■ persistent or chronic cough as occurs with smoking, asthma, or emphysema

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

WHEN USING

When using this product do not use more than directed.

STOP USE

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain, nasal congestion or cough get worse or last more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for
adults & for children even if you do not notice any signs or symptoms.

Directions

■ take only as directed

■ do not exceed 4 doses per 24 hrs. 

• Adults and children 12 yrs and over: take 2 softgels with water every 4 hrs.
• Children 4 to under 12 yrs: ask a doctor
• Children under 4 yrs: do not use

Other information

■ store at room temperature

Inactive ingredients

Polyethylene Glycol400, Propylene Glycol, Povidone, Gelatin, Sorbitol Sorbitan Anhydrous, Glycerin, Allura Red, FD & C Yellow 6/Sunset Yellow, Titanium Dioxide.

Questions or Comments?

Call 1-732-698-5070 Mon-Fri, 9am-5pm EST or visit: www.gencare.health.

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by PROCTER & GAMBLE, owner of the registered trademark Vicks® Dayquil™ Cold and Flu LiquiCaps™.

SPL UNCLASSIFIED SECTION

Distributed by: Gencare Consumer Products, LLC
40E Cotters Ln, Suite A, East Brunswick, NJ 08816

NDC:

72090-005-01- 48 Softgels

INGREDIENTS AND APPEARANCE

GENCARE DAYTIME COLD AND FLU SOFTGEL 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72090-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
Gelatin (UNII: 2G86QN327L)
Sorbitol (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	capsule	Size	19mm
Flavor		Imprint Code	A09
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72090-005-01	48 in 1 BOTTLE; Type 0: Not a Combination Product	12/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/08/2023

Labeler - Pioneer Life Sciences, LLC (014092742)